mHealth for Maternal and Perinatal Health Evaluation of a smartphone application to reduce Adverse Pregnancy Outcomes in Ethiopia STUDY PROTOCOL Maternity Worldwide Ethiopia and Denmark University of Copenhagen Denmark Protocol version 24/03 2013 1 Downloaded From: https://jamanetwork.com/ on 10/01/2021 Table of Contents Table of Contents ..................................................................................................................................... 2 General information ............................................................................................................................... 3 Abbreviations ............................................................................................................................................ 4 Abstract ....................................................................................................................................................... 5 Introduction .............................................................................................................................................. 6 Problem statement .................................................................................................................................. 7 Literature review ..................................................................................................................................... 9 Hypotheses and Study Objectives .................................................................................................... 10 General Objective ............................................................................................................................................ 10 Hypotheses ...................................................................................................................................................... 10 Specific Objectives ........................................................................................................................................... 11 Primary endpoints ........................................................................................................................................... 11 Secondary endpoints ....................................................................................................................................... 11 Tertiary endpoints ........................................................................................................................................... 12 The intervention ................................................................................................................................... 12 Methods .................................................................................................................................................... 13 Study design .................................................................................................................................................... 13 Study area ........................................................................................................................................................ 13 Study population ............................................................................................................................................. 14 Sample size calculation .................................................................................................................................... 14 Sampling technique ......................................................................................................................................... 14 Variables and operational definitions ............................................................................................................. 15 Data collection ................................................................................................................................................. 16 Data analysis .................................................................................................................................................... 19 Quality Control ................................................................................................................................................ 20 Ethical considerations ...................................................................................................................................... 21 Publications ............................................................................................................................................ 21 Work plan ................................................................................................................................................ 22 Budget ....................................................................................................................................................... 22 References ............................................................................................................................................... 23 Appendix .................................................................................................................................................. 26 Appendix 1: Minimum drugs and equipment package ................................................................................... 26 Appendix 2: Health system in study area ........................................................................................................ 26 Appendix 3: Research tools ............................................................................................................................. 28 Appendix 4: Research partners ....................................................................................................................... 29 Appendix 5: Analysis plan ................................................................................................................................ 30 Appendix 6: Work plan .................................................................................................................................... 33 2 Downloaded From: https://jamanetwork.com/ on 10/01/2021 General information Funding Merck for Mothers, Maternity Worldwide Denmark Research team Henriette Svarre, MD, PhD, Anne Marie Frøkjær Barrie, MSc Christina Marie Braüner, BSc, MPH Ida Marie Boas, MSc Jørn Atterman, Msc, PhD Yonas Regassa Guta, MPhil Responsibilities and partners Maternity Worldwide is responsible for funding and implementation of the intervention. University of Copenhagen is responsible for the scientific evaluation of the intervention including protocol development, data quality, analysis and dissemination of results. The content of the safe delivery smartphone application is developed in collaboration. Timeframe Data collection from August 2013 to August 2014 Primary investigators Stine Lund, MD, PhD fellow University of Copenhagen Bjarke Lund Sørensen, MD, PhD University of Copenhagen 3 Downloaded From: https://jamanetwork.com/ on 10/01/2021 Abbreviations AMTSL Active Management of Third Stage Labour ANC Antenatal care BEmO(N)C Basic Emergency Obstetric and (Neonatal) Care CEmO(N)C Comprehensive Emergency Obstetric (and Neonatal) Care EmO(N)C Emergency Obstetric (and Neonatal) Care FMoH Federal Ministry of Health HEP Health Extension Programme HEW Health Extension Worker IMHP Integrated Maternal Health Project KFQ Key Feature Questionnaire MDG Millennium Development Goal mHealth Mobile phones for health MMR Maternal Mortality Ratio MWW Maternity Worldwide MWWDK Maternity Worldwide Denmark OSATS Objective Structured Assessment Tool of Technical Skills PPH Postpartum haemorrhage SBA Skilled Birth Attendance 4 Downloaded From: https://jamanetwork.com/ on 10/01/2021 Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters Design Cluster randomized controlled trial with health facilities as the unit of randomization Area Nole Kaba, Haru, Homa, Genji and Gimbie districts Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities. Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills Study time Data collection from August 2013 to August 2014 5 Downloaded From: https://jamanetwork.com/ on 10/01/2021 Introduction Maternal death, stillbirth, early neonatal death are among the most devastating adverse outcomes of pregnancy. Over 270,000 maternal deaths, 2.65 million stillbirths and 3 million neonatal deaths occur each year worldwide.1-3 Ninety-nine per cent of these deaths take place in low and middle- income countries with the populations of South Asia and sub-Saharan